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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Overheating of Device (1437); Battery Problem (2885); Communication or Transmission Problem (2896)
Patient Problems Burn(s) (1757); Erythema (1840); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2021
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a friend/family member (pt rep) regarding a patient (pt) who was implanted with an implantable neurostimulator (ins). The reason for call was caller says that the recharger (rtm) cord is heating up and burning the patients back. This started "close to a week ago". They did clarify that the pt has an actual burn mark and says its "a circle about the size of a quarter and in the center its kind of bloody and they have been putting triple antibiotic and a band aid on it". Caller says the pt didn't notice this burning because they couldn't feel this burning because "they have nerve burns in their back but noticed it when it wouldn't find his device to charge and saw the burning". Caller says the ins is depleted and stimulation is off. The patient was sent a replacement recharger (rtm).
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12907834
MDR Text Key281507342
Report Number3004209178-2021-17810
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169781702
UDI-Public00643169781702
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/01/2021 Patient Sequence Number: 1
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